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New hope for liver cancer: drug combo trial launches

NCT ID NCT05441475

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a new drug, ABSK-011, combined with the immunotherapy atezolizumab (or standard care) in 118 people with advanced or unresectable hepatocellular carcinoma, a type of liver cancer. The study aims to see if the combination is safe and can shrink tumors. Participants must have a specific genetic marker (FGF19 overexpression) and have not had prior systemic therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABSK-011 (a targeted cancer drug) combined with atezolizumab (an immunotherapy) or standard care
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced liver cancer that has not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. Side effects from the drug combination could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. Subjects should be able and willing to follow the study follow-up and study procedures in the protocol. 2. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old. 3. part a: subjects with advanced or unresectable HCC who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child Pugh score is 5-6. Part b: subjects with advanced or unresectable HCC who must be confirmed histologically or cytologically, are not suitable for curative surgery and / or local regional treatment, and have not previously received systematic treatment or only received first-line systematic treatment- Part C: Subjects with histologically or cytologically confirmed advanced or unresectable HCC who are not eligible for curative surgery and/or locoregional therapy and have not received prior systemic therapy, and who meet the following criteria: 1. Provide archived tumor tissue samples or undergo biopsy for FGF19 overexpression testing at the central laboratory. 2. BCLC stage B or C, Child-Pugh score 5-6, no hepatic encephalopathy, and no ascites requiring medical intervention within 7 days prior to the first dose. 3. At least 1 measurable target lesion per RECIST 1.1. For subjects who received prior locoregional therapy (e.g., transarterial (chemo)embolization, radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, etc.), the target lesion must not have been treated with the above locoregional therapies, or the investigator has confirmed disease progression or absence of clinical benefit in the target lesion after prior locoregional therapy. 4. Treatment with up to one cycle of a PD-1/PD-L1 inhibitor, with or without a VEGF inhibitor, prior to enrollment is permitted. Exclusion Criteria: 1. history of autoimmune diseases 2. have a history of the second primary malignant tumor other than HCC within 5 years before screening, 3. have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels. 4. meningeal metastasis or central nervous system (CNS) metastasis -

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Hubei, Shanghai Municipality, 430030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.